Presentation on theme: "Institutional Review Boards (IRBs) and Human Subjects Research Protection Programs (HRPP) A SHORT COURSE."— Presentation transcript:
1Institutional Review Boards (IRBs) and Human Subjects Research Protection Programs (HRPP) A SHORT COURSE
2Course Content:Part 1: Brief Description of the IRB and Research at Tulane UniversityPart 2: IRB Support Staff FunctionsPart 3: Researcher ResponsibilitiesPart 4: How to submit items for review by the IRBPart 5: Brief discussion about the Informed Consent Process
3Brief Description of the IRB and Research at Tulane University Part 1:Brief Description of the IRB and Research at Tulane University
4What is an IRB? IRB = Institutional Review Board Consists of: At least 5 membersAt least 1 member must have a scientific backgroundAt least 1 must be a non-scientist (1 non-scientist must attend every meeting to achieve quorum)At least 1 non-affiliated member (not affiliated with Tulane)Members should have expertise in the research that will be reviewed
5IRBs are Regulated by State and Federal Regulations FDA (Food and Drug Administration, Title 21 CFR) andOHRP (Office of Human Research Protection, Title 45 CFR Part 46)Also, the IRB must adhere to any Louisiana Law that applies to Human Subjects Research
6Why is Research so heavily Regulated? The history of Research has not always been one of ethics and regulations.Nazi War Crimes and the Nuremberg Trials ( ) and the Tuskegee Syphilis Study ( ) are examples of this.
7The Modern IRB is Born:In 1974, the National Research Act was enacted by US Congress. It created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to oversee and regulate the use of human experimentation in medicine. This Act was developed as partly a response to the disastrous Tuskegee Syphilis Study.The National Research Act mandated specific requirements for institutional review committees which became known as Institutional Review Boards (IRBs).
8The Modern IRB is Born:In 1979, the Belmont Report provided guidance as to how the new rules should be applied. The Belmont Report defined the three philosophical principles relevant to research:Respect for Persons: Adequate information must be provided to subjects of research and voluntarily consent must be obtained.Beneficence: Harm to subjects must be minimized and benefits must be maximized.Justice: The Selection of Subjects must be fair and justified.
9The Primary Concern of the Institutional Review Board (IRB) is to Protect the Rights and Welfare of Research Participants.
10The Main Purpose of IRB Review: To Review Research in accordance with the Criteria for Approval set forth in Section of the Federal RegulationsIncluding:Assessing the risk/benefit ratioEnsuring that informed consent is obtained in an appropriate mannerVerifying that recruitment methods/materials are not misleading or coerciveEnsuring that the selection of subjects is equitable and justifiedand other criteria
11Research at Tulane University: Tulane has 2 IRBs:A Biomedical IRB on the Downtown Campus and a Social/Behavioral IRB on the Uptown CampusThe Tulane University Research Program is considered to be of medium size when compared across the country.Currently, Tulane has approximately 1,000 active protocols
12Tulane IRB Meetings and Members: The Biomedical IRB holds 2 meetings per month(usually the 2nd and 4th Thursday of each month)The Social/Behavioral IRB holds meetings once per month (usually on the last Tuesday of the month)Tulane’s IRBs are made up of physicians, PhDs, pharmacists, nurses, non-scientists, and community members who volunteer their time to review human subject research proposals.
13Accreditation of the Human Research Protection Program Tulane University is currently seeking accreditation of our human research protection program from AAHRPP (The Association for the Accreditation of Human Research Protection Programs,This accreditation seeks to accredit the entire human research protection program for all of Tulane University, not just the IRBs.
14Human Research Protections Office Part 2:Human Research Protections Office
15Tulane University’s Human Research Protection Program Hierarchy: Dr. Laura Levy, Sr. VP of ResearchInstitutional OfficialRoxanne Johnson, MSPHDirector, HRPPBrian Weimer, JDResearch Compliance OfficerMark A. James, PhD.Chair, Biomedical IRBC. Chrisman Wilson, PhD.Chair, Social/Behavioral IRB
16Who are we and what do we do? The HRPO is made up of Coordinators who:Perform preliminary reviews of all submissions to the office for completeness and accuracy (Initial Submissions, Continuing Reviews, Adverse Events, Amendments, etc)Process, maintain, and update all submissions within the HRPO database systemActs as a communication liaison between the IRBs and InvestigatorsPrepare the IRB meeting agendas and distribute review materials to IRB membersTranscribes the IRB meeting minutes and follows up with investigators with IRB requests for approvalServe as a resource to the research community of Tulane University
17Researcher Responsibilities Part 3:Researcher Responsibilities
18Responsibility of the Primary Investigator: All research personnel are required to complete the online Human Subjects CITI Training Course atRecertification of this Training is required every 3 years.It is also the responsibility of the PI to know and understand the regulations and policies prior to initiating any human research.The PI must acknowledge and accept their role to protect the rights and welfare of research subjects by complying with all applicable Regulations.
19Additional Responsibilities of the Primary Investigator: Ensure that the research activities are carried out according to the IRB approved protocolProtect subject confidentiality by storing electronic research data on password protected computers, and paper data in locked cabinets within locked officesFollow HIPAA regulations when the research involves the use or disclosure of Protected Health Information (PHI) and obtain authorization from prospective subjectsEnsure that only IRB approved recruitment materials and research authorizations are usedProvide signed copies of consent and authorization forms to research subjects and keep the originals in secured research filesWhen appropriate, place a copy of the consent form and authorization in the subject’s medical record
20The Submission Process Part 4:The Submission Process
21Submission to the IRB: This section will cover: Initial Submissions Continuing ReviewsAmendmentsUnanticipated Problems/Adverse EventsProtocol Deviations
22Submission to the IRB:Tulane University has adopted an electronic, Internet based submission system entitled IRBNetResearchers are required to register atAll Forms can be found on this website for submissionA Users Guide to using IRBNet is on our website at:Here, you can access the Users Guide, watch a tutorial video of how to submit an initial submission, and access policies and procedures on the use of IRBNet
23How to submit an Application to the IRB: 1. DEVELOP A RESEARCH PROTOCOLThis may come from a grant, an Industry Sponsored protocol, or may be Investigator Initiated. Tips for Writing a Protocol are located on IRBNet.2. OBTAIN THE REQUIRED TULANE IRB FORMSFill out either the Biomedical or Social/Behavioral Application Form for IRB Review. Adhere to the Initial Submission Checklist on IRBNet to complete the submission.3. DETERMINE WHEN THE APPLICATION IS DUEDeadlines for are posted on the IRB website.
24How to submit an Application to the IRB: 4. DO YOU NEED FULL BOARD, EXPEDITED, OR EXEMPT REVIEW?Full board review is needed for protocols that are greater than minimal risk and Exempt/Expedited review is for protocols of minimal risk. More detail concerning the Regulations is on our website.Reminder: Exempt/Expedited protocols do not have a deadline; they are reviewed on an ongoing basis.5. SUBMIT THE COMPLETED APPLICATION TO THE HUMAN RESEARCH PROTECTIONS OFFICERegister and submit the Application and all other applicable information via IRBNet at
25The IRB Review Process: What happens after an Application is submitted?The IRB staff reviews the Application for accuracy and completeness and after the application is accepted, it is processed for review.Exempt/Expedited protocols are reviewed by the Director of the IRB, one of the IRB Chairs, or any member of one of the two IRBs. The PI will be contacted with either a Decision Letter (usually an Approval Letter or a Deferral Letter stating the changes needed to the Submission before Final Approval can be granted).Full Board protocols are placed on the next applicable IRB Meeting for discussion and a decision is voted on.
26The IRB Review Process: What happens after an Application is submitted?After the IRB Meeting, the IRB staff prepares the Minutes from the Meeting and sends out Decision Letters. If Approved, the Research can begin after receipt of the Approval Letter.If Deferred, Investigators have 3 months to make the committee required changes and return any requested information/clarifications to the Human Research Protections Office.Depending upon the Deferral, (for Minor or Major Modifications) the Modifications may be Expedited or may have to be reviewed again by the Convened IRB.
27INVESTIGATORS CANNOT BEGIN ANY PROJECT INVOLVING HUMAN SUBJECTS UNTIL IRBAPPROVAL HAS BEEN GRANTED.
28Continuing Review:Projects are typically approved for a period up to 12 months. The IRB may require a more frequent continuing review depending on the level of risk.Before IRB approval expires, a courtesy notice of expiration is sent to the PI.It is ultimately the PIs responsibility to submit the continuing review report in a timely fashion to endure a lapse in IRB approval does not occur.
29Continuing Review Forms and are available on IRBNet. If the IRB does not receive a complete and accurate Continuing Review Submission, the protocol will go into a Lapse period and will be permanently closed after 30 days.
30Amendments: Revisions to Approved Protocols Steps of Submission:Determine which aspects of the study will be revised (e.g. protocol, consent form, advertisements, personnel, etc.)Obtain the Amendment Form for IRB review from IRBNet and submit with required attachments.
31Amendments: Revisions to Approved Protocols If the revision includes information that must be communicated to currently enrolled subjects (such as altered schedules, revised compensation, newly identified side effects), then you must describe the plan for notifying enrolled subjects and attach any documentation that will be used for this purpose.
32Amendments: Revisions to Approved Protocols Most minor amendments can be processed via Expedited review.Changes which substantially alter the protocol, or change the Risk/Benefit Ratio require review by the full board.Note: The reviewer of the Amendment has the authority to refer any item to the Convened IRB for review.
33Reporting Unanticipated Problems: The Principal Investigator must report to the IRB those unanticipated problems/adverse events occurring locally or at another site, that are:specific to a study approved by a Tulane IRB, and that:involve risk to human subjects or others (i.e. subject family members, research staff) and are:Unanticipated, serious, and related to the research activity;Or are:Expected but occurring at a greater frequency or severity than anticipated. Or,The AE indicates an increase in the risk to participants, regardless of severity.The guidelines for reporting unanticipated problems/adverse events can be found on the IRB website. The Forms can be found on IRBNet.
34Protocol Deviations:The Principal Investigator must also report to the IRB:Any deviations from the protocol or an accidental or unintentional change to the protocol taken without prior approval to eliminate apparent immediate hazard to a research participant.A breach in confidentiality that may involve risk to that individual or others.A complaint of or from a participant that indicates an unanticipated risk or which cannot be resolved by the research staff.The Instructions for reporting Protocol Deviations are found on the IRB website. The Form can be found on IRBNet.
35It’s a process…not a form Part 5:Informed ConsentIt’s a process…not a form
36History of Informed Consent: The requirement that researchers obtain informed consent from research subjects originates with Principal 1 of the Belmont Report:Respect for Persons
37Consent to participate in research is voluntary and informed Respect for Persons:Individuals are treated as autonomous agents. This means that the subjects are not controlled by others and are able to make independent decisionsPersons with diminished autonomy are given protection (e.g. vulnerable subjects such as children, prisoners, mentally disabled)Consent to participate in research is voluntary and informed
38Informed Consent Process: Informed consent is a process that begins when you first approach the potential research subject and continues throughout the course of the study.
39Informed Consent Process: The first contact with research subjects may be through any of the following:Direct AdvertisingMedical Record review to screen for eligible subjectsPhysician Referral
40Informed Consent Process: Obtaining informed consent involves:Providing information to the subject in a language that is understandable to the subject or their representativeEnsuring that the subject understands what they are being asked to doAnswering any questions that the subject may haveAllowing enough time for the subject to think about the research before consenting to participateObtaining voluntary agreement of the subject to participate in the study
41Informed Consent Process: The consent process continues each time that an investigator has contact with a research subject. The consent dialogue is renewed every time that the study is revised, or if new information becomes available that would impact upon a subject’s decision to participate.
42Informed Consent Process: Elements of informed consent include:Information that the study involves researchRisks or DiscomfortsBenefitsAlternativesConfidentialityCompensationContact for additional informationContact information for research subjects rightsStatement that participation is voluntary
43Informed Consent Process: Waivers of Informed Consent:Federal regulations allow for some types of research to be conducted without obtaining written informed consent from research subjects.Typically, waivers are only granted for studies that present no greater than minimal risk. The most frequent types of studies that are eligible for waivers are chart reviews and survey studies.
44Resources for Research and IRBs: www. citiprogram. org www. hhs. ohrp Resources for Research and IRBs: Contact for Tulane IRB: If you have any questions, you can contact the Tulane HRPO at Or, call the office at